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RssI am known as a volume producer; task orientated, detailed and very organized who readily adapts to rapidly changing priorities.

I am experienced in the fields of Documentation and Change Control Systems, Design Controls/Audits and Risk Assessment Analysis / Management, Project Leader, Accounting, and Data Processing.

Environmental

La Mesa, CA

About Me

Industry:

Research

Occupation:

Environmental

Highlights:

Reseached, generated, trained and implemented both manual and electronic Document Control Systems at several companies.

Ideal Companies:

Stable
 

Education level:

Bachelor

Will Relocate:

No

Location:

La Mesa, CA

Work Experiences

1/2008 - /2009

Nanogen, Inc.

Individual Contributor

  • Responsible for coordinating generating and release of 400+ Molecular Assay manufacturing documents on six CE-Real-Time New Product Development projects. • Generating, reviewing, and obtaining approval and release of manufacturing documents for the New Product Development projects. • Scheduling review meetings for review of documents. • Tracking documents through the approval release cycle in accordance with the Quality System Requirements • Interacting with various departments in the course of this project. • Interact with other divisions for approval on review document. • Generate and maintain Design History Files on these new products.

1/2008 - /2008

ACON Laboratory, Inc.

Individual Contributor

  • Responsible for coordinate the accumulation of technical information for design dossiers and technical files for CE Marking. Prepare 510(k) submissions files and Canadian Device Licensing, review and approve CE labeling through internal review process. • Track and coordinate submission and review of design dossier and technical files in support of FDA and EU regulatory filings. • Process interface agreements with OEM customers to ensure compliance with FDA, QSR, IVDD and MDD requirements. • Represent Reguatory in review and approval of labeling bearing FDA 510(k) and CE Mark for ACON and variant brand products. • Responsible for the periodical update of FDA 510(k) cleared and CE marked product lists. • Interface with internal/external auditors in accordance with third party investigations to the Qualtiy System Requirements and compliance issues. • Assist in maintenance activities for company licenses, permits, etc. • Maintain proficiency on regulatory requirements and develop and maintain rapport with regulatory reviewers and project team members.

2/2006 - /2008

Innovacon, Inc., A division of Inverness Medical Innovations

Individual Contributor

  • Responsible for coordinate the accumulation of technical information for design dossiers and technical files for CE Marking. • Track and coordinate submission and review of design dossier and technical files in support of FDA and EU regulatory filings. • Process interface agreements with OEM customers to ensure compliance with FDA, QSR, IVDD and MDD requirements. • Represent Reguatory in review and approval of labeling bearing FDA 510(k) and CE Mark for Innovacon, Inc. and variant brand products. • Liaison to FDA, Notified Body and Authorized Representative O Interface with FDA reviewers and/or Notified Body through written and oral communication as needed. O Interface with Authorized Representative to ensure compliance with EU countries for CE Marking submission and negotiastions to ensure a timely approval. • Assist in maintenance activities for company licenses, permits, etc. including DEA activities. • Review proposed changes for Regulatory impact in change control board meetings (CCB)

2/2004 - /2006

Applied Biotech Inc., A division of Inverness Medical Innovations

Individual Contributor

  • Responsible for conducting support activities for the CE Marking process, 510(k) submissions, Technical File review, Label Copy review FDA/customer audits, Canadian Device Licensing, State FDA registration certificate, QSR/ISO company-wide training, customer/regulatory agency staff interaction, Document Change Request/Variance review in regard to regulatory requirements. • Review of labeling for CE Marking • Regulatory guidance for product review and design • Assist Research and Development in the creation of the Technical File and review for compliance • Direct interaction with federal, state, international regulatory agencies and customer regulatory staff. • CLIA documentation and application submission • Assist in maintenance activities for company licenses, permits, etc.

2/2002 - /2006

Respironics, Inc.

Individual Contributor

  • Administers the Documentation Control Department ensuring the company’s documentation is clear, concise and accurate and meets the quality standards of ISO 9001:2000, ISO 13485, EN46001 Medical Device Directive (MDD) 93/42/EEC and QSR and all other domestic and international regulations. Certified in FDA Quality Systems Inspection Techniques (FDA SIT) auditing. • Performs system administration responsibilities for the Document Control / MRP / QA database. • Manages processes to support ISO / GMP / CE in the areas of change control, documentation control and quality library. • Develops updates & maintains documentation procedures necessary to maintain compliance with all applicable regulations. • Assist engineering, manufacturing, purchasing, custom support and distribution groups to maintain appropriate documentation of procedures and policies for standards compliance. • Responsible for screening, hiring & training of department staff. • Establishes & communicates high standards of performance and provides feedback, training & coaching based on criteria that are consistent and measurable. • Responsible for supervising & evaluating performance of all department personnel. • Set, maintain and track goals and objectives for the Document Control Department in conjunction with Quality Assurance / Regulatory Affairs, Special Projects on an annual basis. • Provides service to internal and external customers to the best of their knowledge.

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